Trial Outcomes & Findings for A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia (NCT NCT00386334)
NCT ID: NCT00386334
Last Updated: 2016-03-14
Results Overview
The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
COMPLETED
PHASE4
388 participants
Baseline (week 0), Day 1 (post first dose)-12 weeks
2016-03-14
Participant Flow
823 participants were screened. Two participants in each arm completed all assessments for the double blind period but discontinued before starting the follow up period (withdrew consent; did not take any single blind medication in follow up period).
Participant milestones
| Measure |
Placebo
Placebo tablets
|
Eszopiclone
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Double Blind Period
STARTED
|
194
|
194
|
|
Double Blind Period
COMPLETED
|
148
|
147
|
|
Double Blind Period
NOT COMPLETED
|
46
|
47
|
|
Follow up:2 Week Placebo, 2 Week no Drug
STARTED
|
146
|
145
|
|
Follow up:2 Week Placebo, 2 Week no Drug
COMPLETED
|
143
|
144
|
|
Follow up:2 Week Placebo, 2 Week no Drug
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablets
|
Eszopiclone
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Double Blind Period
Adverse Event
|
9
|
14
|
|
Double Blind Period
Protocol Violation
|
1
|
1
|
|
Double Blind Period
Withdrawal by Subject
|
9
|
13
|
|
Double Blind Period
Lack of Efficacy
|
20
|
11
|
|
Double Blind Period
Didnt Meet Entry/Randomization Criteria
|
4
|
5
|
|
Double Blind Period
Other
|
3
|
3
|
|
Follow up:2 Week Placebo, 2 Week no Drug
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
Baseline characteristics by cohort
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
Total
n=388 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
194 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
388 Participants
n=5 Participants
|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
72.0 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
181 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
359 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
194 participants
n=5 Participants
|
194 participants
n=7 Participants
|
388 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.28 Kilograms/Meters squared
STANDARD_DEVIATION 4.98 • n=5 Participants
|
28.25 Kilograms/Meters squared
STANDARD_DEVIATION 4.90 • n=7 Participants
|
27.76 Kilograms/Meters squared
STANDARD_DEVIATION 4.96 • n=5 Participants
|
|
Height
|
165.90 Centimeters
STANDARD_DEVIATION 9.83 • n=5 Participants
|
164.70 Centimeters
STANDARD_DEVIATION 10.04 • n=7 Participants
|
165.30 Centimeters
STANDARD_DEVIATION 9.94 • n=5 Participants
|
|
Weight
|
75.44 kilograms
STANDARD_DEVIATION 17.07 • n=5 Participants
|
76.98 kilograms
STANDARD_DEVIATION 16.72 • n=7 Participants
|
76.21 kilograms
STANDARD_DEVIATION 16.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose)-12 weeksPopulation: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure. Number of participants in each arm 194, 194.
The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
Outcome measures
| Measure |
Placebo
n=191 Participants
Placebo tablets
|
Eszopiclone
n=191 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.
|
33.18 minutes
Standard Deviation 50.02
|
63.24 minutes
Standard Deviation 52.76
|
SECONDARY outcome
Timeframe: Weeks 0, 3, 6, 9, 12, 14, 16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure.
The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
Week 3 (n=191,190)
|
20.65 minutes
Standard Deviation 42.34 • Interval 13.68 to 25.72
|
51.02 minutes
Standard Deviation 46.43 • Interval 44.88 to 56.99
|
|
Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
Week 6 (n=191,191)
|
32.47 minutes
Standard Deviation 53.31 • Interval 25.29 to 39.67
|
61.91 minutes
Standard Deviation 54.15 • Interval 56.18 to 70.63
|
|
Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
Week 9 (n=191,191)
|
38.73 minutes
Standard Deviation 57.73 • Interval 30.99 to 46.75
|
69.00 minutes
Standard Deviation 61.58 • Interval 63.0 to 78.83
|
|
Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
Week 12 (n=191,191)
|
40.86 minutes
Standard Deviation 60.74 • Interval 33.16 to 49.63
|
70.97 minutes
Standard Deviation 62.18 • Interval 64.95 to 81.5
|
|
Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
Week 14 (n=191,191)
|
42.78 minutes
Standard Deviation 66.52 • Interval 35.54 to 53.54
|
50.12 minutes
Standard Deviation 68.25 • Interval 44.83 to 62.92
|
|
Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
Week 16 (n=191,191)
|
37.43 minutes
Standard Deviation 67.68 • Interval 31.36 to 49.07
|
47.17 minutes
Standard Deviation 63.68 • Interval 42.89 to 60.69
|
SECONDARY outcome
Timeframe: Weeks 0, 3, 6, 9, 12, 14, 16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Week 0 (n=192,191)
|
294.03 minutes
Standard Deviation 63.30
|
297.86 minutes
Standard Deviation 56.14
|
|
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Week 3 (n=192,192)
|
314.53 minutes
Standard Deviation 63.52
|
347.37 minutes
Standard Deviation 57.17
|
|
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Week 6 (n=192,193)
|
326.25 minutes
Standard Deviation 65.41
|
358.72 minutes
Standard Deviation 61.47
|
|
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Week 9 (n=192,193)
|
332.47 minutes
Standard Deviation 65.25
|
365.80 minutes
Standard Deviation 64.97
|
|
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Week 12 (n=192,193)
|
334.69 minutes
Standard Deviation 69.91
|
367.75 minutes
Standard Deviation 66.08
|
|
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Weeks 3,6,9,12 (double blind average)(n=192,193)
|
326.98 minutes
Standard Deviation 62.88
|
360.08 minutes
Standard Deviation 59.40
|
|
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Week 14 (n=192,193)
|
336.55 minutes
Standard Deviation 71.13
|
347.12 minutes
Standard Deviation 72.97
|
|
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Week 16 (n=192,193)
|
331.29 minutes
Standard Deviation 72.53
|
344.20 minutes
Standard Deviation 74.91
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - Week12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
Outcome measures
| Measure |
Placebo
n=191 Participants
Placebo tablets
|
Eszopiclone
n=191 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.
|
-19.92 minutes
Standard Deviation 46.99
|
-24.62 minutes
Standard Deviation 46.32
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
Week 3 (n=191,190)
|
-13.34 minutes
Standard Deviation 41.97 • Interval 0.78 to 0.9
|
-21.89 minutes
Standard Deviation 44.38 • Interval 0.64 to 0.74
|
|
Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
Week 6 (n=191,191)
|
-19.69 minutes
Standard Deviation 52.08 • Interval 0.7 to 0.83
|
-24.13 minutes
Standard Deviation 49.20 • Interval 0.59 to 0.7
|
|
Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
Week 9 (n=191,191)
|
-23.02 minutes
Standard Deviation 50.75 • Interval 0.66 to 0.79
|
-24.21 minutes
Standard Deviation 52.62 • Interval 0.57 to 0.68
|
|
Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
Week 12 (n=191,191)
|
-23.54 minutes
Standard Deviation 54.14 • Interval 0.64 to 0.78
|
-28.35 minutes
Standard Deviation 49.72 • Interval 0.53 to 0.64
|
|
Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
Week 14 (n=191,191)
|
-25.08 minutes
Standard Deviation 58.99 • Interval 0.61 to 0.75
|
-17.00 minutes
Standard Deviation 55.55 • Interval 0.62 to 0.77
|
|
Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
Week 16 (n=191,191)
|
-24.61 minutes
Standard Deviation 55.22 • Interval 0.62 to 0.76
|
-18.73 minutes
Standard Deviation 51.67 • Interval 0.6 to 0.74
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Week 0 (n=192,191)
|
82.17 minutes
Standard Deviation 74.08
|
75.68 minutes
Standard Deviation 56.63
|
|
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Week 3 (n=192,192)
|
68.80 minutes
Standard Deviation 64.51
|
54.69 minutes
Standard Deviation 46.16
|
|
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Week 6 (n=192,193)
|
62.57 minutes
Standard Deviation 60.06
|
52.11 minutes
Standard Deviation 48.66
|
|
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Week 9 (n=192,193)
|
59.23 minutes
Standard Deviation 52.05
|
51.75 minutes
Standard Deviation 51.79
|
|
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Week 12 (n=192,193)
|
58.69 minutes
Standard Deviation 51.84
|
47.66 minutes
Standard Deviation 39.70
|
|
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Weeks 3,6,9,12 (double blind average)(n=192,193)
|
62.32 minutes
Standard Deviation 54.82
|
51.51 minutes
Standard Deviation 43.87
|
|
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Week 14 (n=192,193)
|
57.23 minutes
Standard Deviation 49.94
|
58.89 minutes
Standard Deviation 45.89
|
|
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Week 16 (n=192,193)
|
57.62 minutes
Standard Deviation 51.99
|
57.17 minutes
Standard Deviation 45.40
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) -week 12Population: Intent to treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last observation carried forward (LOCF). Number of participants in each arm 194, 194.
Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo tablets
|
Eszopiclone
n=191 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.
|
-14.75 minutes
Standard Deviation 38.45
|
-36.40 minutes
Standard Deviation 41.29
|
SECONDARY outcome
Timeframe: Baseline (week 0), weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
Week 3 (n=188,190)
|
-8.55 minutes
Standard Deviation 35.80 • Interval 0.73 to 0.93
|
-29.26 minutes
Standard Deviation 37.68 • Interval 0.48 to 0.61
|
|
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
Week 6 (n=189,191)
|
-13.46 minutes
Standard Deviation 39.01 • Interval 0.65 to 0.86
|
-36.57 minutes
Standard Deviation 43.11 • Interval 0.39 to 0.51
|
|
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
Week 9 (n=189,191)
|
-17.67 minutes
Standard Deviation 44.13 • Interval 0.57 to 0.77
|
-40.32 minutes
Standard Deviation 45.12 • Interval 0.36 to 0.49
|
|
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
Week 12 (n=189,191)
|
-19.13 minutes
Standard Deviation 43.39 • Interval 0.54 to 0.74
|
-39.61 minutes
Standard Deviation 46.48 • Interval 0.35 to 0.48
|
|
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
Week 14 (n=189,191)
|
-22.72 minutes
Standard Deviation 45.00 • Interval 0.46 to 0.64
|
-32.27 minutes
Standard Deviation 47.55 • Interval 0.39 to 0.55
|
|
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
Week 16 (n=189,191)
|
-20.18 minutes
Standard Deviation 48.06 • Interval 0.45 to 0.64
|
-31.13 minutes
Standard Deviation 51.35 • Interval 0.38 to 0.54
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Week 0 (n=190,191)
|
90.86 minutes
Standard Deviation 51.77
|
92.66 minutes
Standard Deviation 58.11
|
|
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Week 3 (n=190,192)
|
83.17 minutes
Standard Deviation 49.63
|
64.33 minutes
Standard Deviation 45.97
|
|
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Week 6 (n=192,193)
|
77.86 minutes
Standard Deviation 48.82
|
56.49 minutes
Standard Deviation 44.25
|
|
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Week 9 (n=192,193)
|
73.33 minutes
Standard Deviation 49.71
|
52.75 minutes
Standard Deviation 42.51
|
|
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Week 12 (n=192,193)
|
72.02 minutes
Standard Deviation 50.44
|
53.45 minutes
Standard Deviation 44.23
|
|
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=192,193)
|
76.59 minutes
Standard Deviation 47.52
|
56.68 minutes
Standard Deviation 42.40
|
|
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Week 14 (n=192,193)
|
68.39 minutes
Standard Deviation 51.87
|
60.71 minutes
Standard Deviation 47.07
|
|
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Week 16 (n=192,193)
|
71.27 minutes
Standard Deviation 54.61
|
61.84 minutes
Standard Deviation 48.93
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - Week12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo tablets
|
Eszopiclone
n=191 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.
|
-0.27 number of awakenings
Standard Deviation 0.72
|
-0.56 number of awakenings
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
Week 3 (n=188,190)
|
-0.16 number of awakenings
Standard Deviation .63 • Interval -0.27 to -0.1
|
-0.46 number of awakenings
Standard Deviation 0.70 • Interval -0.51 to -0.34
|
|
Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
Week 6 (n=189,191)
|
-0.24 number of awakenings
Standard Deviation 0.77 • Interval -0.38 to -0.17
|
-0.56 number of awakenings
Standard Deviation 0.83 • Interval -0.64 to -0.44
|
|
Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
Week 9 (n=189,191)
|
-0.33 number of awakenings
Standard Deviation 0.81 • Interval -0.47 to -0.26
|
-0.57 number of awakenings
Standard Deviation 0.88 • Interval -0.66 to -0.45
|
|
Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
Week 12 (n=189,191)
|
-0.35 number of awakenings
Standard Deviation 0.83 • Interval -0.5 to -0.28
|
-0.65 number of awakenings
Standard Deviation 0.90 • Interval -0.75 to -0.52
|
|
Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
Week 14 (n=189,191)
|
-0.38 number of awakenings
Standard Deviation 0.85 • Interval -0.54 to -0.3
|
-0.46 number of awakenings
Standard Deviation 0.96 • Interval -0.57 to -0.33
|
|
Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
Week 16 (n=189,191)
|
-0.35 number of awakenings
Standard Deviation 0.87 • Interval -0.53 to -0.29
|
-0.44 number of awakenings
Standard Deviation 0.97 • Interval -0.57 to -0.33
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Week 14 (n=192,193)
|
1.58 number of awakenings
Standard Deviation 0.99
|
1.65 number of awakenings
Standard Deviation 1.15
|
|
Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Week 16 (n=192,193)
|
1.61 number of awakenings
Standard Deviation 0.97
|
1.66 number of awakenings
Standard Deviation 1.11
|
|
Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Week 0 (n=190,191)
|
1.95 number of awakenings
Standard Deviation 1.00
|
2.10 number of awakenings
Standard Deviation 1.10
|
|
Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Week 3 (n=190,192)
|
1.78 number of awakenings
Standard Deviation 0.91
|
1.66 number of awakenings
Standard Deviation 0.96
|
|
Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Week 6 (n=192,193)
|
1.72 number of awakenings
Standard Deviation 0.93
|
1.55 number of awakenings
Standard Deviation 1.00
|
|
Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Week 9 (n=192,193)
|
1.62 number of awakenings
Standard Deviation 0.94
|
1.54 number of awakenings
Standard Deviation 1.01
|
|
Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Week 12 (n=192,193)
|
1.61 number of awakenings
Standard Deviation 0.94
|
1.46 number of awakenings
Standard Deviation 1.03
|
|
Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=192,193)
|
1.68 number of awakenings
Standard Deviation 0.90
|
1.55 number of awakenings
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - Week12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo tablets
|
Eszopiclone
n=191 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period
|
0.68 units on a scale
Standard Deviation 1.35
|
1.39 units on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
Week 3 (n=188,190)
|
0.37 units on a scale
Standard Deviation 0.98 • Interval 0.24 to 0.52
|
1.12 units on a scale
Standard Deviation 1.18 • Interval 0.94 to 1.22
|
|
Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
Week 6 (n=189,191)
|
0.62 units on a scale
Standard Deviation 1.31 • Interval 0.49 to 0.83
|
1.35 units on a scale
Standard Deviation 1.43 • Interval 1.16 to 1.5
|
|
Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
Week 9 (n=189,191)
|
0.81 units on a scale
Standard Deviation 1.58 • Interval 0.68 to 1.06
|
1.52 units on a scale
Standard Deviation 1.62 • Interval 1.31 to 1.69
|
|
Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
Week 12 (n=189,191)
|
0.92 units on a scale
Standard Deviation 1.77 • Interval 0.78 to 1.19
|
1.57 units on a scale
Standard Deviation 1.73 • Interval 1.35 to 1.76
|
|
Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
Week 14 (n=189,191)
|
1.02 units on a scale
Standard Deviation 1.88 • Interval 0.89 to 1.34
|
1.26 units on a scale
Standard Deviation 2.07 • Interval 1.03 to 1.48
|
|
Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
Week 16 (n=189, 191)
|
0.88 units on a scale
Standard Deviation 1.96 • Interval 0.78 to 1.23
|
1.22 units on a scale
Standard Deviation 2.06 • Interval 1.03 to 1.48
|
SECONDARY outcome
Timeframe: weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Week 0 (n=190,191)
|
4.84 units on a scale
Standard Deviation 1.83
|
4.68 units on a scale
Standard Deviation 1.94
|
|
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Week 3 (n=190,190)
|
5.22 units on a scale
Standard Deviation 1.62
|
5.77 units on a scale
Standard Deviation 1.82
|
|
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Week 6 (n=192,193)
|
5.48 units on a scale
Standard Deviation 1.56
|
6.01 units on a scale
Standard Deviation 1.77
|
|
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Week 9 (n=192,193)
|
5.67 units on a scale
Standard Deviation 1.57
|
6.17 units on a scale
Standard Deviation 1.71
|
|
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Week 12 (n=192,193)
|
5.78 units on a scale
Standard Deviation 1.58
|
6.22 units on a scale
Standard Deviation 1.70
|
|
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=192, 193)
|
5.54 units on a scale
Standard Deviation 1.50
|
6.04 units on a scale
Standard Deviation 1.68
|
|
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Week 14 (n=192,193)
|
5.88 units on a scale
Standard Deviation 1.60
|
5.91 units on a scale
Standard Deviation 1.76
|
|
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Week 16 (n=192,193)
|
5.73 units on a scale
Standard Deviation 1.65
|
5.88 units on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=188 Participants
Placebo tablets
|
Eszopiclone
n=190 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.
|
0.69 units on a scale
Standard Deviation 1.33
|
1.33 units on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
Week 3 (n=188, 190)
|
0.40 units on a scale
Standard Deviation 0.97
|
1.07 units on a scale
Standard Deviation 1.16
|
|
Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
Week 6 (n=189, 191)
|
0.62 units on a scale
Standard Deviation 1.29
|
1.30 units on a scale
Standard Deviation 1.44
|
|
Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
Week 9 (n=189, 191)
|
0.82 units on a scale
Standard Deviation 1.54
|
1.46 units on a scale
Standard Deviation 1.63
|
|
Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
Week 12 (n=189, 191)
|
0.93 units on a scale
Standard Deviation 1.74
|
1.49 units on a scale
Standard Deviation 1.73
|
|
Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
Week 14 (n=189,191)
|
1.00 units on a scale
Standard Deviation 1.88
|
1.23 units on a scale
Standard Deviation 2.08
|
|
Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
Week 16 (n=189,191)
|
0.88 units on a scale
Standard Deviation 1.96
|
1.15 units on a scale
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-reported Depth of Sleep at Various Study Time Points
Week 3 (n=190,192)
|
5.29 units on a scale
Standard Deviation 1.62
|
5.76 units on a scale
Standard Deviation 1.78
|
|
Mean Subject-reported Depth of Sleep at Various Study Time Points
Week 6 (n=192,193)
|
5.51 units on a scale
Standard Deviation 1.58
|
6.00 units on a scale
Standard Deviation 1.75
|
|
Mean Subject-reported Depth of Sleep at Various Study Time Points
Week 9 (n=192,193)
|
5.71 units on a scale
Standard Deviation 1.58
|
6.15 units on a scale
Standard Deviation 1.73
|
|
Mean Subject-reported Depth of Sleep at Various Study Time Points
Week 12 (n=192, 193)
|
5.82 units on a scale
Standard Deviation 1.59
|
6.18 units on a scale
Standard Deviation 1.70
|
|
Mean Subject-reported Depth of Sleep at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=192,193)
|
5.58 units on a scale
Standard Deviation 1.52
|
6.02 units on a scale
Standard Deviation 1.68
|
|
Mean Subject-reported Depth of Sleep at Various Study Time Points
Week 14 (n=192,193)
|
5.89 units on a scale
Standard Deviation 1.63
|
5.92 units on a scale
Standard Deviation 1.78
|
|
Mean Subject-reported Depth of Sleep at Various Study Time Points
Week 0 (n=190,191)
|
4.87 units on a scale
Standard Deviation 1.88
|
4.72 units on a scale
Standard Deviation 1.90
|
|
Mean Subject-reported Depth of Sleep at Various Study Time Points
Week 16 (n=192,193)
|
5.76 units on a scale
Standard Deviation 1.69
|
5.84 units on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo tablets
|
Eszopiclone
n=192 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period
|
0.61 units on a scale
Standard Deviation 1.30
|
1.02 units on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
Week 3 (n=189,191)
|
0.39 units on a scale
Standard Deviation 0.90
|
0.76 units on a scale
Standard Deviation 1.03
|
|
Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
Week 6 (n=189,192)
|
0.55 units on a scale
Standard Deviation 1.28
|
0.99 units on a scale
Standard Deviation 1.29
|
|
Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
Week 9 (n=189,192)
|
0.72 units on a scale
Standard Deviation 1.53
|
1.10 units on a scale
Standard Deviation 1.54
|
|
Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
Week 12 (n=189,192)
|
0.78 units on a scale
Standard Deviation 1.72
|
1.21 units on a scale
Standard Deviation 1.64
|
|
Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
Week 14 (n=189,192)
|
0.85 units on a scale
Standard Deviation 1.81
|
1.05 units on a scale
Standard Deviation 1.92
|
|
Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
Week 16 (n=189,192)
|
0.78 units on a scale
Standard Deviation 1.89
|
0.97 units on a scale
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-reported Daytime Alertness at Various Study Time Points.
Week 0 (n=192,193)
|
5.34 units on a scale
Standard Deviation 1.97
|
5.42 units on a scale
Standard Deviation 2.11
|
|
Mean Subject-reported Daytime Alertness at Various Study Time Points.
Week 3 (n=190,191)
|
5.74 units on a scale
Standard Deviation 1.72
|
6.18 units on a scale
Standard Deviation 1.78
|
|
Mean Subject-reported Daytime Alertness at Various Study Time Points.
Week 6 (n=190,192)
|
5.89 units on a scale
Standard Deviation 1.57
|
6.41 units on a scale
Standard Deviation 1.68
|
|
Mean Subject-reported Daytime Alertness at Various Study Time Points.
Week 9 (n=190,192)
|
6.06 units on a scale
Standard Deviation 1.51
|
6.52 units on a scale
Standard Deviation 1.59
|
|
Mean Subject-reported Daytime Alertness at Various Study Time Points.
Week 12 (n=190,192)
|
6.13 units on a scale
Standard Deviation 1.51
|
6.64 units on a scale
Standard Deviation 1.58
|
|
Mean Subject-reported Daytime Alertness at Various Study Time Points.
Weeks 3,6,9,12 (double blind average)(n=190,192)
|
5.95 units on a scale
Standard Deviation 1.50
|
6.44 units on a scale
Standard Deviation 1.59
|
|
Mean Subject-reported Daytime Alertness at Various Study Time Points.
Week 14 (n=190,192)
|
6.19 units on a scale
Standard Deviation 1.52
|
6.47 units on a scale
Standard Deviation 1.63
|
|
Mean Subject-reported Daytime Alertness at Various Study Time Points.
Week 16 (n=190,192)
|
6.13 units on a scale
Standard Deviation 1.59
|
6.39 units on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo tablets
|
Eszopiclone
n=192 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period
|
0.53 units on a scale
Standard Deviation 1.29
|
0.91 units on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
Week 3 (n=189,191)
|
0.36 units on a scale
Standard Deviation 0.88
|
0.69 units on a scale
Standard Deviation 0.98
|
|
Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
Week 6 (n=189,192)
|
0.46 units on a scale
Standard Deviation 1.25
|
0.87 units on a scale
Standard Deviation 1.27
|
|
Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
Week 9 (n=189,192)
|
0.62 units on a scale
Standard Deviation 1.54
|
0.98 units on a scale
Standard Deviation 1.50
|
|
Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
Week 12 (n=189,192)
|
0.69 units on a scale
Standard Deviation 1.68
|
1.08 units on a scale
Standard Deviation 1.60
|
|
Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
Week 14 (n=189,192)
|
0.75 units on a scale
Standard Deviation 1.81
|
0.96 units on a scale
Standard Deviation 1.87
|
|
Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
Week 16 (n=189,192)
|
0.69 units on a scale
Standard Deviation 1.87
|
0.87 units on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) \& average for double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-reported Ability to Function at Various Study Time Points
Week 0 (n=192,193)
|
5.62 units on a scale
Standard Deviation 2.07
|
5.69 units on a scale
Standard Deviation 2.14
|
|
Mean Subject-reported Ability to Function at Various Study Time Points
Week 3 (n=190,191)
|
5.98 units on a scale
Standard Deviation 1.79
|
6.38 units on a scale
Standard Deviation 1.79
|
|
Mean Subject-reported Ability to Function at Various Study Time Points
Week 6 (n=190,192)
|
6.09 units on a scale
Standard Deviation 1.61
|
6.57 units on a scale
Standard Deviation 1.68
|
|
Mean Subject-reported Ability to Function at Various Study Time Points
Week 9 (n=190,192)
|
6.24 units on a scale
Standard Deviation 1.56
|
6.69 units on a scale
Standard Deviation 1.57
|
|
Mean Subject-reported Ability to Function at Various Study Time Points
Week 12 (n=190,192)
|
6.32 units on a scale
Standard Deviation 1.54
|
6.79 units on a scale
Standard Deviation 1.55
|
|
Mean Subject-reported Ability to Function at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=190,192)
|
6.16 units on a scale
Standard Deviation 1.55
|
6.61 units on a scale
Standard Deviation 1.59
|
|
Mean Subject-reported Ability to Function at Various Study Time Points
Week 14 (n=190,192)
|
6.38 units on a scale
Standard Deviation 1.54
|
6.66 units on a scale
Standard Deviation 1.57
|
|
Mean Subject-reported Ability to Function at Various Study Time Points
Week 16 (n=190,192)
|
6.31 units on a scale
Standard Deviation 1.62
|
6.57 units on a scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Baseliine (week 0), Day 1 (post first dose) - week 12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo tablets
|
Eszopiclone
n=192 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.
|
0.50 units on a scale
Standard Deviation 1.30
|
0.96 units on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
Week 3 (n=189,191)
|
0.32 units on a scale
Standard Deviation 0.89
|
0.73 units on a scale
Standard Deviation 0.96
|
|
Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
Week 6 (n=189,192)
|
0.43 units on a scale
Standard Deviation 1.29
|
0.93 units on a scale
Standard Deviation 1.24
|
|
Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
Week 9 (n=189,192)
|
0.60 units on a scale
Standard Deviation 1.53
|
1.03 units on a scale
Standard Deviation 1.48
|
|
Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
Week 12 (n=189,192)
|
0.66 units on a scale
Standard Deviation 1.71
|
1.14 units on a scale
Standard Deviation 1.57
|
|
Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
Week 14 (n=189,192)
|
0.72 units on a scale
Standard Deviation 1.81
|
1.00 units on a scale
Standard Deviation 1.87
|
|
Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
Week 16 (n=189,192)
|
0.66 units on a scale
Standard Deviation 1.89
|
0.93 units on a scale
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) \& average for the double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-reported Ability to Concentrate at Various Study Time Points
Week 0 (n=192,193)
|
5.66 units on a scale
Standard Deviation 2.08
|
5.63 units on a scale
Standard Deviation 2.15
|
|
Mean Subject-reported Ability to Concentrate at Various Study Time Points
Week 3 (n=190,191)
|
5.99 units on a scale
Standard Deviation 1.78
|
6.37 units on a scale
Standard Deviation 1.80
|
|
Mean Subject-reported Ability to Concentrate at Various Study Time Points
Week 6 (n=190,192)
|
6.10 units on a scale
Standard Deviation 1.62
|
6.57 units on a scale
Standard Deviation 1.69
|
|
Mean Subject-reported Ability to Concentrate at Various Study Time Points
Week 9 (n=190,192)
|
6.27 units on a scale
Standard Deviation 1.54
|
6.67 units on a scale
Standard Deviation 1.58
|
|
Mean Subject-reported Ability to Concentrate at Various Study Time Points
Week 12 (n=190,192)
|
6.33 units on a scale
Standard Deviation 1.52
|
6.77 units on a scale
Standard Deviation 1.57
|
|
Mean Subject-reported Ability to Concentrate at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=190,192)
|
6.17 units on a scale
Standard Deviation 1.54
|
6.60 units on a scale
Standard Deviation 1.60
|
|
Mean Subject-reported Ability to Concentrate at Various Study Time Points
Week 14 (n=190,192)
|
6.39 units on a scale
Standard Deviation 1.53
|
6.64 units on a scale
Standard Deviation 1.58
|
|
Mean Subject-reported Ability to Concentrate at Various Study Time Points
Week 16 (n=190,192)
|
6.33 units on a scale
Standard Deviation 1.61
|
6.56 units on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=189 Participants
Placebo tablets
|
Eszopiclone
n=192 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period
|
0.52 units on a scale
Standard Deviation 1.28
|
0.87 units on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
Week 3 (n=189,191)
|
0.35 units on a scale
Standard Deviation 0.88
|
0.68 units on a scale
Standard Deviation 0.99
|
|
Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
Week 6 (n=189,192)
|
0.46 units on a scale
Standard Deviation 1.26
|
0.84 units on a scale
Standard Deviation 1.27
|
|
Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
Week 9 (n=189,192)
|
0.61 units on a scale
Standard Deviation 1.52
|
0.93 units on a scale
Standard Deviation 1.51
|
|
Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
Week 12 (n=189,192)
|
0.65 units on a scale
Standard Deviation 1.71
|
1.02 units on a scale
Standard Deviation 1.62
|
|
Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
Week 14 (n=189,192)
|
0.72 units on a scale
Standard Deviation 1.82
|
0.89 units on a scale
Standard Deviation 1.92
|
|
Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
Week 16 (n=189,192)
|
0.64 units on a scale
Standard Deviation 1.90
|
0.80 units on a scale
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), \& average for double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-reported Physical Well-Being at Various Study Time Points
Week 12 (n=190,192)
|
6.11 units on a scale
Standard Deviation 1.52
|
6.65 units on a scale
Standard Deviation 1.53
|
|
Mean Subject-reported Physical Well-Being at Various Study Time Points
Week 0 (n=192,193)
|
5.45 units on a scale
Standard Deviation 1.98
|
5.62 units on a scale
Standard Deviation 2.14
|
|
Mean Subject-reported Physical Well-Being at Various Study Time Points
Week 3 (n=190,191)
|
5.80 units on a scale
Standard Deviation 1.74
|
6.30 units on a scale
Standard Deviation 1.77
|
|
Mean Subject-reported Physical Well-Being at Various Study Time Points
Week 6 (n=190,192)
|
5.92 units on a scale
Standard Deviation 1.57
|
6.46 units on a scale
Standard Deviation 1.65
|
|
Mean Subject-reported Physical Well-Being at Various Study Time Points
Week 9 (n=190,192)
|
6.06 units on a scale
Standard Deviation 1.53
|
6.56 units on a scale
Standard Deviation 1.56
|
|
Mean Subject-reported Physical Well-Being at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=190,192)
|
5.97 units on a scale
Standard Deviation 1.51
|
6.49 units on a scale
Standard Deviation 1.56
|
|
Mean Subject-reported Physical Well-Being at Various Study Time Points
Week 14 (n=190,192)
|
6.18 units on a scale
Standard Deviation 1.53
|
6.51 units on a scale
Standard Deviation 1.56
|
|
Mean Subject-reported Physical Well-Being at Various Study Time Points
Week 16 (n=190,192)
|
6.09 units on a scale
Standard Deviation 1.61
|
6.43 units on a scale
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose)- week 12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=110 Participants
Placebo tablets
|
Eszopiclone
n=93 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period
|
-0.78 number of naps
Standard Deviation 2.30
|
-1.23 number of naps
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
Week 12 (n=110, 93)
|
-0.96 number of naps
Standard Deviation 2.88
|
-1.18 number of naps
Standard Deviation 2.58
|
|
Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
Week 3 (n=110,92)
|
-0.39 number of naps
Standard Deviation 2.04
|
-1.15 number of naps
Standard Deviation 2.02
|
|
Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
Week 6 (n=110,93)
|
-0.80 number of naps
Standard Deviation 2.49
|
-1.26 number of naps
Standard Deviation 2.21
|
|
Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
Week 9 (n=110, 93)
|
-0.96 number of naps
Standard Deviation 2.67
|
-1.33 number of naps
Standard Deviation 2.51
|
|
Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
Week 14 (n=110,93)
|
-0.71 number of naps
Standard Deviation 2.93
|
-1.00 number of naps
Standard Deviation 2.31
|
|
Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
Week 16 (n=110,93)
|
-0.92 number of naps
Standard Deviation 2.79
|
-1.29 number of naps
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
Week 0 (n=111,94)
|
4.03 number of naps
Standard Deviation 4.41
|
3.88 number of naps
Standard Deviation 3.55
|
|
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
Week 3 (n=110,92)
|
3.67 number of naps
Standard Deviation 4.67
|
2.76 number of naps
Standard Deviation 2.96
|
|
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
Week 6 (n=110,93)
|
3.26 number of naps
Standard Deviation 4.25
|
2.64 number of naps
Standard Deviation 3.00
|
|
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
Week 9 (n=110,93)
|
3.10 number of naps
Standard Deviation 4.57
|
2.57 number of naps
Standard Deviation 2.63
|
|
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
Week 12 (n=110,93)
|
3.10 number of naps
Standard Deviation 5.05
|
2.71 number of naps
Standard Deviation 3.06
|
|
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
Weeks 3,6,9,12 (double blind average)(n=110,93)
|
3.28 number of naps
Standard Deviation 4.51
|
2.66 number of naps
Standard Deviation 2.74
|
|
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
Week 14 (n=110,93)
|
3.35 number of naps
Standard Deviation 5.32
|
2.90 number of naps
Standard Deviation 3.12
|
|
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
Week 16 (n=110,93)
|
3.14 number of naps
Standard Deviation 4.63
|
2.61 number of naps
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=110 Participants
Placebo tablets
|
Eszopiclone
n=93 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period
|
-36.02 minutes
Standard Deviation 125.59
|
-60.06 minutes
Standard Deviation 156.49
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
Week 6 (n=110,93)
|
-40.02 minutes
Standard Deviation 140.47
|
-65.99 minutes
Standard Deviation 163.12
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
Week 9 (n=110,93)
|
-40.25 minutes
Standard Deviation 146.42
|
-56.59 minutes
Standard Deviation 184.47
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
Week 3 (n=110,92)
|
-21.66 minutes
Standard Deviation 116.53
|
-59.06 minutes
Standard Deviation 158.00
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
Week 12 (n=110,93)
|
-42.15 minutes
Standard Deviation 136.85
|
-58.22 minutes
Standard Deviation 163.87
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
Week 14 (n=110,93)
|
-27.28 minutes
Standard Deviation 142.36
|
-44.48 minutes
Standard Deviation 165.67
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
Week 16 (n=110,93)
|
-38.14 minutes
Standard Deviation 137.69
|
-49.15 minutes
Standard Deviation 202.13
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-Reported Total Nap Time at Various Study Time Points
Week 0 (n=111,94)
|
189.31 minutes
Standard Deviation 262.08
|
171.62 minutes
Standard Deviation 237.75
|
|
Mean Subject-Reported Total Nap Time at Various Study Time Points
Week 3 (n=110,92)
|
169.24 minutes
Standard Deviation 253.66
|
114.43 minutes
Standard Deviation 151.26
|
|
Mean Subject-Reported Total Nap Time at Various Study Time Points
Week 6 (n=110,93)
|
150.88 minutes
Standard Deviation 226.90
|
106.99 minutes
Standard Deviation 133.85
|
|
Mean Subject-Reported Total Nap Time at Various Study Time Points
Week 9 (n=110,93)
|
150.65 minutes
Standard Deviation 234.11
|
116.39 minutes
Standard Deviation 156.42
|
|
Mean Subject-Reported Total Nap Time at Various Study Time Points
Week 12 (n=110,93)
|
148.75 minutes
Standard Deviation 256.87
|
114.76 minutes
Standard Deviation 149.73
|
|
Mean Subject-Reported Total Nap Time at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=110,93)
|
154.88 minutes
Standard Deviation 237.82
|
112.92 minutes
Standard Deviation 135.34
|
|
Mean Subject-Reported Total Nap Time at Various Study Time Points
Week 14 (n=110,93)
|
163.61 minutes
Standard Deviation 274.13
|
128.50 minutes
Standard Deviation 173.51
|
|
Mean Subject-Reported Total Nap Time at Various Study Time Points
Week 16 (n=110,93)
|
152.76 minutes
Standard Deviation 246.50
|
123.83 minutes
Standard Deviation 173.58
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=110 Participants
Placebo tablets
|
Eszopiclone
n=93 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period
|
-2.44 percentage of total asleep time
Standard Deviation 8.29
|
-2.98 percentage of total asleep time
Standard Deviation 5.53
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 14 (n=110,93)
|
-2.31 percentage of total asleep time
Standard Deviation 9.22
|
-2.14 percentage of total asleep time
Standard Deviation 5.82
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 16 (n=110,93)
|
-2.55 percentage of total asleep time
Standard Deviation 8.62
|
-2.38 percentage of total asleep time
Standard Deviation 6.72
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 3 (n=110,92)
|
-1.78 percentage of total asleep time
Standard Deviation 7.00
|
-2.77 percentage of total asleep time
Standard Deviation 5.57
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 6 (n=110,93)
|
-2.52 percentage of total asleep time
Standard Deviation 9.09
|
-3.16 percentage of total asleep time
Standard Deviation 5.80
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 9 (n=110,93)
|
-2.72 percentage of total asleep time
Standard Deviation 9.26
|
-2.94 percentage of total asleep time
Standard Deviation 6.24
|
|
Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 12 (n=110,93)
|
-2.76 percentage of total asleep time
Standard Deviation 8.98
|
-3.04 percentage of total asleep time
Standard Deviation 5.82
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), \& average for double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 0 (n=111,94)
|
9.05 percentage of total asleep time
Standard Deviation 13.89
|
7.02 percentage of total asleep time
Standard Deviation 8.34
|
|
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 3 (n=110,92)
|
7.35 percentage of total asleep time
Standard Deviation 11.94
|
4.33 percentage of total asleep time
Standard Deviation 5.53
|
|
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 6 (n=110,93)
|
6.61 percentage of total asleep time
Standard Deviation 11.73
|
3.91 percentage of total asleep time
Standard Deviation 4.83
|
|
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 9 (n=110,93)
|
6.41 percentage of total asleep time
Standard Deviation 11.04
|
4.13 percentage of total asleep time
Standard Deviation 5.15
|
|
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 12 (n=110,93)
|
6.37 percentage of total asleep time
Standard Deviation 11.77
|
4.04 percentage of total asleep time
Standard Deviation 5.00
|
|
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=110,93)
|
6.68 percentage of total asleep time
Standard Deviation 11.37
|
4.09 percentage of total asleep time
Standard Deviation 4.75
|
|
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 14 (n=110,93)
|
6.82 percentage of total asleep time
Standard Deviation 11.17
|
4.93 percentage of total asleep time
Standard Deviation 6.19
|
|
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Week 16 (n=110,93)
|
6.57 percentage of total asleep time
Standard Deviation 11.00
|
4.69 percentage of total asleep time
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo tablets
|
Eszopiclone
n=61 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
|
14.40 minutes
Standard Deviation 38.14
|
17.96 minutes
Standard Deviation 34.71
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 1 (n=60,58)
|
3.72 minutes
Standard Deviation 54.09
|
14.97 minutes
Standard Deviation 36.91
|
|
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 4 (n=61,61)
|
17.21 minutes
Standard Deviation 39.97
|
16.89 minutes
Standard Deviation 41.00
|
|
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 7 (n=62,61)
|
15.72 minutes
Standard Deviation 57.85
|
22.12 minutes
Standard Deviation 41.02
|
|
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 12 (n=62,61)
|
18.93 minutes
Standard Deviation 44.73
|
18.08 minutes
Standard Deviation 52.57
|
|
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 13 (n=62,61)
|
15.36 minutes
Standard Deviation 51.72
|
-0.60 minutes
Standard Deviation 56.17
|
|
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 15 (n=62,61)
|
13.82 minutes
Standard Deviation 43.48
|
4.06 minutes
Standard Deviation 47.60
|
SECONDARY outcome
Timeframe: Weeks 0,1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) \& average for double-blind(average of weeks1,4,7,12 values).
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 0 (n=64,61)
|
351.06 minutes
Standard Deviation 86.05
|
367.95 minutes
Standard Deviation 60.86
|
|
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 15 (n=68,67)
|
365.73 minutes
Standard Deviation 74.47
|
369.23 minutes
Standard Deviation 64.82
|
|
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 1 (n=64,64)
|
354.11 minutes
Standard Deviation 94.76
|
381.52 minutes
Standard Deviation 73.83
|
|
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 4 (n=67,67)
|
366.69 minutes
Standard Deviation 78.34
|
382.39 minutes
Standard Deviation 69.41
|
|
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 7 (n=68,67)
|
368.58 minutes
Standard Deviation 86.48
|
386.96 minutes
Standard Deviation 63.89
|
|
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 12 (n=68,67)
|
368.70 minutes
Standard Deviation 83.39
|
382.04 minutes
Standard Deviation 69.98
|
|
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Weeks 1,4,7,12 (double blind average)(n=68,67)
|
365.13 minutes
Standard Deviation 79.31
|
383.30 minutes
Standard Deviation 63.78
|
|
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Week 13 (n=68,67)
|
366.47 minutes
Standard Deviation 81.33
|
364.87 minutes
Standard Deviation 74.16
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo tablets
|
Eszopiclone
n=61 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
|
0.00 minutes
Standard Deviation 40.75
|
1.47 minutes
Standard Deviation 26.76
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
Week 1 (n=60,58)
|
9.06 minutes
Standard Deviation 74.76
|
-0.25 minutes
Standard Deviation 18.92
|
|
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
Week 4 (n=61,61)
|
-2.16 minutes
Standard Deviation 44.61
|
-1.48 minutes
Standard Deviation 27.74
|
|
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
Week 7 (n=62,61)
|
0.12 minutes
Standard Deviation 52.95
|
-1.62 minutes
Standard Deviation 26.28
|
|
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
Week 12 (n=62,61)
|
-3.92 minutes
Standard Deviation 36.22
|
9.34 minutes
Standard Deviation 57.32
|
|
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
Week 13 (n=62,61)
|
-0.69 minutes
Standard Deviation 59.32
|
16.13 minutes
Standard Deviation 66.04
|
|
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
Week 15 (n=62,61)
|
-3.66 minutes
Standard Deviation 39.21
|
6.44 minutes
Standard Deviation 36.59
|
SECONDARY outcome
Timeframe: Weeks 0,1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. Mean values reported:baseline(week0), double-blind (weeks 1,4,7,12), single-blind follow-up(week13), non-drug treatment follow-up(week15) \& average for double-blind (average of weeks 1,4,7,12 values). Last Observation Carried Forward.
Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Week 0 (n=64,61)
|
31.34 minutes
Standard Deviation 65.06
|
23.89 minutes
Standard Deviation 24.50
|
|
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Week 1 (n=64,64)
|
37.74 minutes
Standard Deviation 78.14
|
26.72 minutes
Standard Deviation 36.56
|
|
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Week 4 (n=67,67)
|
28.55 minutes
Standard Deviation 35.46
|
26.62 minutes
Standard Deviation 43.36
|
|
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Week 7 (n=68,67)
|
31.06 minutes
Standard Deviation 42.82
|
26.89 minutes
Standard Deviation 33.34
|
|
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Week 12 (n=68,67)
|
27.89 minutes
Standard Deviation 38.78
|
36.93 minutes
Standard Deviation 57.69
|
|
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Weeks 1,4,7,12 (double blind average)(n=68,67)
|
31.20 minutes
Standard Deviation 36.89
|
29.22 minutes
Standard Deviation 35.92
|
|
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Week 13 (n=68,67)
|
30.40 minutes
Standard Deviation 41.05
|
43.06 minutes
Standard Deviation 64.37
|
|
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Week 15 (n=68,67)
|
28.80 minutes
Standard Deviation 37.75
|
34.35 minutes
Standard Deviation 40.34
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo tablets
|
Eszopiclone
n=61 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
|
4.50 minutes
Standard Deviation 19.54
|
-4.24 minutes
Standard Deviation 22.91
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 1 (n=59,58)
|
3.17 minutes
Standard Deviation 16.23
|
-6.59 minutes
Standard Deviation 23.78
|
|
Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 4 (n=61,61)
|
4.67 minutes
Standard Deviation 23.36
|
-3.88 minutes
Standard Deviation 26.95
|
|
Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 7 (n=62,61)
|
6.57 minutes
Standard Deviation 30.27
|
-4.19 minutes
Standard Deviation 25.25
|
|
Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 12 (n=62,61)
|
3.24 minutes
Standard Deviation 17.90
|
-2.54 minutes
Standard Deviation 24.42
|
|
Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 13 (n=62,61)
|
4.98 minutes
Standard Deviation 22.35
|
0.68 minutes
Standard Deviation 23.79
|
|
Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 15 (n=62,61)
|
7.74 minutes
Standard Deviation 25.70
|
-0.27 minutes
Standard Deviation 24.10
|
SECONDARY outcome
Timeframe: weeks 0,1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) \& average for double-blind phase(average of weeks 1,4,7,12 values).
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 13 (n=68,67)
|
64.09 minutes
Standard Deviation 31.39
|
63.01 minutes
Standard Deviation 27.84
|
|
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 0 (n=64,61)
|
60.27 minutes
Standard Deviation 29.51
|
63.75 minutes
Standard Deviation 29.11
|
|
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 1 (n=63,64)
|
63.53 minutes
Standard Deviation 31.09
|
55.39 minutes
Standard Deviation 22.11
|
|
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 4 (n=67,67)
|
64.16 minutes
Standard Deviation 32.11
|
58.86 minutes
Standard Deviation 24.51
|
|
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 7 (n=68,67)
|
65.81 minutes
Standard Deviation 35.11
|
58.09 minutes
Standard Deviation 22.41
|
|
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 12 (n=68,67)
|
62.41 minutes
Standard Deviation 30.09
|
60.22 minutes
Standard Deviation 23.10
|
|
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Weeks 1,4,7,12 (double blind average)(n=68,67)
|
63.69 minutes
Standard Deviation 29.90
|
58.21 minutes
Standard Deviation 20.76
|
|
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Week 15 (n=68,67)
|
67.07 minutes
Standard Deviation 37.40
|
62.27 minutes
Standard Deviation 25.77
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo tablets
|
Eszopiclone
n=61 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
|
0.87 number of awakenings
Standard Deviation 3.65
|
-0.18 number of awakenings
Standard Deviation 4.28
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
Week 1 (n=59,58)
|
0.76 number of awakenings
Standard Deviation 3.09
|
-0.54 number of awakenings
Standard Deviation 4.19
|
|
Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
Week 4 (n=61,61)
|
0.79 number of awakenings
Standard Deviation 4.62
|
0.04 number of awakenings
Standard Deviation 5.22
|
|
Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
Week 7 (n=62,61)
|
0.88 number of awakenings
Standard Deviation 4.73
|
-0.21 number of awakenings
Standard Deviation 5.05
|
|
Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
Week 12 (n=62,61)
|
0.95 number of awakenings
Standard Deviation 4.60
|
-0.10 number of awakenings
Standard Deviation 4.93
|
|
Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
Week 13 (n=62,61)
|
1.10 number of awakenings
Standard Deviation 4.69
|
0.01 number of awakenings
Standard Deviation 4.93
|
|
Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
Week 15 (n=62,61)
|
1.36 number of awakenings
Standard Deviation 4.35
|
-0.13 number of awakenings
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: Weeks 0,1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Week 0 (n=64,61)
|
21.49 number of awakenings
Standard Deviation 7.53
|
22.84 number of awakenings
Standard Deviation 6.94
|
|
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Week 1 (n=63,64)
|
22.42 number of awakenings
Standard Deviation 7.17
|
21.86 number of awakenings
Standard Deviation 5.96
|
|
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Week 4 (n=67,67)
|
22.28 number of awakenings
Standard Deviation 7.30
|
22.51 number of awakenings
Standard Deviation 6.16
|
|
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Week 7 (n=68,67)
|
22.52 number of awakenings
Standard Deviation 7.93
|
22.19 number of awakenings
Standard Deviation 6.08
|
|
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Week 12 (n=68,67)
|
22.36 number of awakenings
Standard Deviation 7.76
|
22.37 number of awakenings
Standard Deviation 6.25
|
|
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Weeks 1,4,7,12 (double blind average)(n=68,67)
|
22.40 number of awakenings
Standard Deviation 7.15
|
22.27 number of awakenings
Standard Deviation 5.66
|
|
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Week 13 (n=68,67)
|
22.55 number of awakenings
Standard Deviation 7.57
|
22.48 number of awakenings
Standard Deviation 7.30
|
|
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Week 15 (n=68,67)
|
22.87 number of awakenings
Standard Deviation 7.71
|
22.38 number of awakenings
Standard Deviation 5.99
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=58 Participants
Placebo tablets
|
Eszopiclone
n=58 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
|
1.61 number of naps
Standard Deviation 9.06
|
-2.67 number of naps
Standard Deviation 12.61
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 1 (n=57,55)
|
1.33 number of naps
Standard Deviation 9.15
|
-0.62 number of naps
Standard Deviation 12.92
|
|
Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 4 (n=57,58)
|
1.02 number of naps
Standard Deviation 11.73
|
-3.43 number of naps
Standard Deviation 13.36
|
|
Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 7 (n=58,58)
|
1.68 number of naps
Standard Deviation 10.63
|
-2.83 number of naps
Standard Deviation 16.76
|
|
Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 12 (n=58,58)
|
1.86 number of naps
Standard Deviation 9.83
|
-3.47 number of naps
Standard Deviation 15.15
|
|
Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 13 (n=58,58)
|
2.73 number of naps
Standard Deviation 10.54
|
-4.58 number of naps
Standard Deviation 13.69
|
|
Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 15 (n=58,58)
|
3.41 number of naps
Standard Deviation 11.22
|
-0.64 number of naps
Standard Deviation 12.16
|
SECONDARY outcome
Timeframe: Week 0,1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 0 (n=62,58)
|
20.52 number of naps
Standard Deviation 15.63
|
22.33 number of naps
Standard Deviation 15.42
|
|
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 1 (n=57,55)
|
20.94 number of naps
Standard Deviation 14.99
|
21.69 number of naps
Standard Deviation 15.38
|
|
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 4 (n=57,58)
|
20.63 number of naps
Standard Deviation 15.38
|
18.90 number of naps
Standard Deviation 13.85
|
|
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 7 (n=58,58)
|
21.07 number of naps
Standard Deviation 14.93
|
19.50 number of naps
Standard Deviation 15.18
|
|
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 12 (n=58,58)
|
21.25 number of naps
Standard Deviation 14.29
|
18.86 number of naps
Standard Deviation 15.18
|
|
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Weeks 1,4,7,12 (double blind average)(n=58,58)
|
21.01 number of naps
Standard Deviation 13.90
|
19.66 number of naps
Standard Deviation 12.91
|
|
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 13 (n=58,58)
|
22.12 number of naps
Standard Deviation 15.97
|
17.75 number of naps
Standard Deviation 12.66
|
|
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Week 15 (n=58,58)
|
22.80 number of naps
Standard Deviation 15.03
|
21.69 number of naps
Standard Deviation 14.45
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=58 Participants
Placebo tablets
|
Eszopiclone
n=58 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
|
21.26 minutes
Standard Deviation 196.66
|
-40.91 minutes
Standard Deviation 307.98
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
Week 4 (n=57,58)
|
6.37 minutes
Standard Deviation 252.54
|
-56.87 minutes
Standard Deviation 336.01
|
|
Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
Week 1 (n=57,55)
|
2.37 minutes
Standard Deviation 184.85
|
6.56 minutes
Standard Deviation 285.45
|
|
Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
Week 7 (n=58,58)
|
23.03 minutes
Standard Deviation 220.20
|
-31.85 minutes
Standard Deviation 428.85
|
|
Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
Week 12 (n=58,58)
|
38.86 minutes
Standard Deviation 229.45
|
-73.67 minutes
Standard Deviation 338.69
|
|
Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
Week 13 (n=58,58)
|
64.84 minutes
Standard Deviation 275.99
|
-87.50 minutes
Standard Deviation 291.01
|
|
Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
Week 15 (n=58,58)
|
61.28 minutes
Standard Deviation 235.24
|
-1.99 minutes
Standard Deviation 240.85
|
SECONDARY outcome
Timeframe: Week 0,1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
Week 0 (n=62,58)
|
418.49 minutes
Standard Deviation 368.31
|
438.02 minutes
Standard Deviation 325.66
|
|
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
Week 15 (n=58,58)
|
452.93 minutes
Standard Deviation 310.68
|
436.03 minutes
Standard Deviation 297.32
|
|
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
Week 1 (n=57,55)
|
399.19 minutes
Standard Deviation 298.18
|
445.84 minutes
Standard Deviation 358.33
|
|
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
Week 4 (n=57,58)
|
403.18 minutes
Standard Deviation 328.59
|
381.15 minutes
Standard Deviation 335.03
|
|
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
Week 7 (n=58,58)
|
414.68 minutes
Standard Deviation 315.20
|
406.16 minutes
Standard Deviation 387.87
|
|
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
Week 12 (n=58,58)
|
430.50 minutes
Standard Deviation 313.11
|
364.34 minutes
Standard Deviation 313.03
|
|
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
Weeks 1,4,7,12 (double blind average)(n=58,58)
|
412.91 minutes
Standard Deviation 292.66
|
397.11 minutes
Standard Deviation 305.65
|
|
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
Week 13 (n=58,58)
|
456.48 minutes
Standard Deviation 352.10
|
350.52 minutes
Standard Deviation 262.61
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=58 Participants
Placebo tablets
|
Eszopiclone
n=58 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.
|
0.45 percentage of total asleep time
Standard Deviation 7.84
|
-1.75 percentage of total asleep time
Standard Deviation 8.46
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points
Week 15 (n=58,58)
|
0.95 percentage of total asleep time
Standard Deviation 8.11
|
-0.04 percentage of total asleep time
Standard Deviation 7.41
|
|
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points
Week 1 (n=57,55)
|
1.38 percentage of total asleep time
Standard Deviation 13.89
|
-0.17 percentage of total asleep time
Standard Deviation 7.95
|
|
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points
Week 4 (n=57,58)
|
-0.56 percentage of total asleep time
Standard Deviation 8.64
|
-2.14 percentage of total asleep time
Standard Deviation 9.54
|
|
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points
Week 7 (n=58,58)
|
0.18 percentage of total asleep time
Standard Deviation 9.21
|
-1.75 percentage of total asleep time
Standard Deviation 11.22
|
|
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points
Week 12 (n=58,58)
|
0.46 percentage of total asleep time
Standard Deviation 7.76
|
-2.70 percentage of total asleep time
Standard Deviation 9.24
|
|
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points
Week 13 (n=58,58)
|
0.94 percentage of total asleep time
Standard Deviation 7.96
|
-2.63 percentage of total asleep time
Standard Deviation 8.98
|
SECONDARY outcome
Timeframe: Week 0,1,4,7,12,13,15Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) \& average for double-blind phase(average of weeks 1,4,7,12 values).
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablets
|
Eszopiclone
n=69 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
Week 13 (n=58,58)
|
15.66 percentage of total asleep time
Standard Deviation 13.84
|
11.43 percentage of total asleep time
Standard Deviation 8.28
|
|
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
Week 0 (n=62,58)
|
15.12 percentage of total asleep time
Standard Deviation 15.32
|
14.05 percentage of total asleep time
Standard Deviation 9.41
|
|
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
Week 1 (n=57,55)
|
16.29 percentage of total asleep time
Standard Deviation 17.55
|
13.89 percentage of total asleep time
Standard Deviation 10.19
|
|
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
Week 4 (n=57,58)
|
14.35 percentage of total asleep time
Standard Deviation 13.63
|
11.92 percentage of total asleep time
Standard Deviation 9.24
|
|
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
Week 7 (n=58,58)
|
14.90 percentage of total asleep time
Standard Deviation 12.97
|
12.30 percentage of total asleep time
Standard Deviation 10.35
|
|
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
Week 12 (n=58,58)
|
15.18 percentage of total asleep time
Standard Deviation 13.23
|
11.36 percentage of total asleep time
Standard Deviation 9.14
|
|
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
Weeks 1,4,7,12 (double blind average)(n=58,58)
|
15.16 percentage of total asleep time
Standard Deviation 12.87
|
12.30 percentage of total asleep time
Standard Deviation 8.64
|
|
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
Week 15 (n=58,58)
|
15.66 percentage of total asleep time
Standard Deviation 12.42
|
14.01 percentage of total asleep time
Standard Deviation 8.85
|
SECONDARY outcome
Timeframe: Baseline (week 0), Day 1 (post first dose) - week 12Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Outcome measures
| Measure |
Placebo
n=180 Participants
Placebo tablets
|
Eszopiclone
n=182 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period
|
-3.42 units on a scale
Standard Deviation 4.38
|
-5.67 units on a scale
Standard Deviation 5.26
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
Week 3 (n=179,181)
|
-2.74 units on a scale
Standard Deviation 4.51
|
-4.94 units on a scale
Standard Deviation 5.38
|
|
Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
Week 6 (n=180,181)
|
-3.35 units on a scale
Standard Deviation 4.89
|
-5.67 units on a scale
Standard Deviation 5.88
|
|
Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
Week 9 (n=180,182)
|
-3.55 units on a scale
Standard Deviation 5.10
|
-5.89 units on a scale
Standard Deviation 5.88
|
|
Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
Week 12 (n=180,182)
|
-4.05 units on a scale
Standard Deviation 5.15
|
-6.18 units on a scale
Standard Deviation 5.96
|
|
Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
Week 14 (n=181,182)
|
-3.93 units on a scale
Standard Deviation 5.25
|
-4.06 units on a scale
Standard Deviation 5.88
|
|
Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
Week 16 (n=181,182)
|
-2.96 units on a scale
Standard Deviation 5.16
|
-2.96 units on a scale
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: Weeks 0,3,6,9,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Insomnia Severity Index Total Scores at Various Study Time Points
Week 14 (n=182,185)
|
12.30 units on a scale
Standard Deviation 5.68
|
11.94 units on a scale
Standard Deviation 5.56
|
|
Mean Insomnia Severity Index Total Scores at Various Study Time Points
Week 16 (n=182,185)
|
13.28 units on a scale
Standard Deviation 5.39
|
13.05 units on a scale
Standard Deviation 5.49
|
|
Mean Insomnia Severity Index Total Scores at Various Study Time Points
Week 0 (n=192,190)
|
16.34 units on a scale
Standard Deviation 4.18
|
16.12 units on a scale
Standard Deviation 4.81
|
|
Mean Insomnia Severity Index Total Scores at Various Study Time Points
Week 3 (n=180,183)
|
13.52 units on a scale
Standard Deviation 5.11
|
11.09 units on a scale
Standard Deviation 5.48
|
|
Mean Insomnia Severity Index Total Scores at Various Study Time Points
Week 6 (n=181,184)
|
12.87 units on a scale
Standard Deviation 5.26
|
10.40 units on a scale
Standard Deviation 5.87
|
|
Mean Insomnia Severity Index Total Scores at Various Study Time Points
Week 9 (n=181,185)
|
12.66 units on a scale
Standard Deviation 5.58
|
10.12 units on a scale
Standard Deviation 5.77
|
|
Mean Insomnia Severity Index Total Scores at Various Study Time Points
Week 12 (n=181,185)
|
12.16 units on a scale
Standard Deviation 5.51
|
9.84 units on a scale
Standard Deviation 5.63
|
|
Mean Insomnia Severity Index Total Scores at Various Study Time Points
Weeks 3,6,9,12 (double blind average)(n=181,185)
|
12.80 units on a scale
Standard Deviation 4.87
|
10.36 units on a scale
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 6, 12, 16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale
Week 6 (n=164,165)
|
1.01 units on a scale
Standard Deviation 7.73
|
1.00 units on a scale
Standard Deviation 7.28
|
|
Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale
Week 12 (n=165,166)
|
1.38 units on a scale
Standard Deviation 7.60
|
1.01 units on a scale
Standard Deviation 7.14
|
|
Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale
Week 16 (n=166,166)
|
0.69 units on a scale
Standard Deviation 7.99
|
0.39 units on a scale
Standard Deviation 6.78
|
SECONDARY outcome
Timeframe: Weeks 0,6,12,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Physical Component Summary of the Short Form-36 Scale Scores.
Week 0 (n=192,190)
|
43.99 units on a scale
Standard Deviation 10.67
|
45.39 units on a scale
Standard Deviation 9.78
|
|
Mean Physical Component Summary of the Short Form-36 Scale Scores.
Week 6 (n=165,168)
|
45.06 units on a scale
Standard Deviation 10.98
|
46.08 units on a scale
Standard Deviation 10.00
|
|
Mean Physical Component Summary of the Short Form-36 Scale Scores.
Week 12 (n=166,169)
|
45.38 units on a scale
Standard Deviation 10.57
|
46.12 units on a scale
Standard Deviation 9.42
|
|
Mean Physical Component Summary of the Short Form-36 Scale Scores.
Week 16 (n=167,169)
|
44.70 units on a scale
Standard Deviation 10.98
|
45.51 units on a scale
Standard Deviation 9.80
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 6,12,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores
Week 6 (n=164,165)
|
-0.44 units on a scale
Standard Deviation 7.45
|
0.96 units on a scale
Standard Deviation 8.59
|
|
Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores
Week 12 (n=165,166)
|
-0.94 units on a scale
Standard Deviation 8.00
|
0.83 units on a scale
Standard Deviation 8.54
|
|
Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores
Week 16 (n=166,166)
|
-1.22 units on a scale
Standard Deviation 8.94
|
0.20 units on a scale
Standard Deviation 7.46
|
SECONDARY outcome
Timeframe: Weeks 0,6,12,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)\& non-drug treatment follow-up(week 16).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Mental Component Summary of the Short Form-36 Scale Scores
Week 0 (n=192,190)
|
49.69 units on a scale
Standard Deviation 9.33
|
49.29 units on a scale
Standard Deviation 10.04
|
|
Mean Mental Component Summary of the Short Form-36 Scale Scores
Week 6 (n=165,168)
|
49.49 units on a scale
Standard Deviation 10.03
|
49.96 units on a scale
Standard Deviation 10.03
|
|
Mean Mental Component Summary of the Short Form-36 Scale Scores
Week 12 (n=166,169)
|
48.98 units on a scale
Standard Deviation 10.19
|
49.86 units on a scale
Standard Deviation 9.09
|
|
Mean Mental Component Summary of the Short Form-36 Scale Scores
Week 16 (n=167,169)
|
48.68 units on a scale
Standard Deviation 10.61
|
49.23 units on a scale
Standard Deviation 9.92
|
SECONDARY outcome
Timeframe: Baseline (week 0), Weeks 6,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability \& includes: work/school, social life, family life/home responsibilities, days lost \&days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Change From Baseline in the Sheehan Disability Scale Total Score.
Week 12 (n=165,166)
|
-3.73 units on a scale
Standard Deviation 7.59
|
-4.48 units on a scale
Standard Deviation 7.72
|
|
Mean Change From Baseline in the Sheehan Disability Scale Total Score.
Week 6 (n=164,165)
|
-2.60 units on a scale
Standard Deviation 7.63
|
-4.05 units on a scale
Standard Deviation 7.42
|
|
Mean Change From Baseline in the Sheehan Disability Scale Total Score.
Week 14 (n=166,166)
|
-3.11 units on a scale
Standard Deviation 7.88
|
-3.52 units on a scale
Standard Deviation 7.15
|
|
Mean Change From Baseline in the Sheehan Disability Scale Total Score.
Week 16 (n=166,166)
|
-3.33 units on a scale
Standard Deviation 8.09
|
-2.47 units on a scale
Standard Deviation 7.14
|
SECONDARY outcome
Timeframe: Weeks 0,6,12,14,16Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)\& follow-up(weeks 14,16).
Outcome measures
| Measure |
Placebo
n=194 Participants
Placebo tablets
|
Eszopiclone
n=194 Participants
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Mean Sheehan Disability Total Scores
Week 0 (n=192,190)
|
11.38 units on a scale
Standard Deviation 7.80
|
11.13 units on a scale
Standard Deviation 7.63
|
|
Mean Sheehan Disability Total Scores
Week 6 (n=165,168)
|
8.87 units on a scale
Standard Deviation 6.82
|
7.52 units on a scale
Standard Deviation 6.81
|
|
Mean Sheehan Disability Total Scores
Week 12 (n=166,169)
|
7.70 units on a scale
Standard Deviation 6.48
|
7.08 units on a scale
Standard Deviation 6.85
|
|
Mean Sheehan Disability Total Scores
Week 14 (n=166,166)
|
8.37 units on a scale
Standard Deviation 7.21
|
8.03 units on a scale
Standard Deviation 7.10
|
|
Mean Sheehan Disability Total Scores
Week 16 (n=167,169)
|
8.12 units on a scale
Standard Deviation 7.10
|
9.06 units on a scale
Standard Deviation 7.71
|
Adverse Events
Placebo
Eszopiclone
Serious adverse events
| Measure |
Placebo
Placebo tablets
|
Eszopiclone
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Gastrointestinal disorders
Appendicitis Perforated
|
0.52%
1/194 • Number of events 1
|
0.00%
0/194
|
|
Hepatobiliary disorders
Cholecystisis
|
0.00%
0/194
|
0.52%
1/194 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.52%
1/194 • Number of events 1
|
0.00%
0/194
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/194
|
0.52%
1/194 • Number of events 1
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.00%
0/194
|
0.52%
1/194 • Number of events 1
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/194
|
0.52%
1/194 • Number of events 1
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/194
|
0.52%
1/194 • Number of events 1
|
Other adverse events
| Measure |
Placebo
Placebo tablets
|
Eszopiclone
Eszopiclone 2 mg tablets
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.52%
1/194 • Number of events 1
|
4.6%
9/194 • Number of events 13
|
|
Gastrointestinal disorders
Stomach Discomfort
|
1.5%
3/194 • Number of events 7
|
3.1%
6/194 • Number of events 7
|
|
Gastrointestinal disorders
Dry Mouth
|
2.1%
4/194 • Number of events 4
|
2.1%
4/194 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/194 • Number of events 6
|
2.1%
4/194 • Number of events 4
|
|
General disorders
Fatigue
|
1.5%
3/194 • Number of events 3
|
2.6%
5/194 • Number of events 5
|
|
General disorders
Pain
|
1.5%
3/194 • Number of events 4
|
2.1%
4/194 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
12/194 • Number of events 13
|
5.7%
11/194 • Number of events 11
|
|
Infections and infestations
Influenza
|
2.6%
5/194 • Number of events 5
|
2.1%
4/194 • Number of events 4
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.5%
3/194 • Number of events 4
|
2.1%
4/194 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.1%
8/194 • Number of events 8
|
1.5%
3/194 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
5/194 • Number of events 6
|
1.0%
2/194 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.52%
1/194 • Number of events 1
|
2.1%
4/194 • Number of events 6
|
|
Nervous system disorders
Headache
|
12.4%
24/194 • Number of events 45
|
13.9%
27/194 • Number of events 51
|
|
Nervous system disorders
Dysgeusia
|
1.5%
3/194 • Number of events 4
|
12.4%
24/194 • Number of events 35
|
|
Nervous system disorders
Dizziness
|
1.5%
3/194 • Number of events 3
|
4.1%
8/194 • Number of events 16
|
|
Nervous system disorders
Somnolence
|
2.1%
4/194 • Number of events 5
|
2.6%
5/194 • Number of events 5
|
|
Psychiatric disorders
Anxiety
|
1.0%
2/194 • Number of events 2
|
2.1%
4/194 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
5/194 • Number of events 5
|
2.6%
5/194 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
2.1%
4/194 • Number of events 4
|
2.6%
5/194 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
4/194 • Number of events 5
|
1.0%
2/194 • Number of events 2
|
Additional Information
Lunesta Medical Director
Sepracor Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee In addition to the \<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER